Development of an Advanced Manufacturing Technology for Continuous Drug Substance Production.

ABSTRACT: We describe the early conceptual development of a candidate advanced manufacturing technology (AMT) which enables the synthesis of albuterol sulfate, a bronchodilator used for the treatment of asthma, and an API currently listed on the FDA's drug shortage list. The candidate AMT system is currently under construction for the automated production of +2,000 mg/h of albuterol sulfate via a new synthetic pathway with a 78.4% solution yield when operating at a 1.0 mL/min flow rate basis. Additionally, system throughput can be scaled 10-fold with minor modifications. The authors plan to apply for AMT approval of this technology under the FDA's new AMT designation program. Key engineering design strategies are highlighted for successful translation of traditional batch synthetic methods toward co

SUBMITTER: Gregory DG 

PROVIDER: S-EPMC12856833 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature